Insurance and indemnity for human research

Duty to be insured

The National Health and Medical Research Council’s National Statement on Ethical Conduct in Human Research (2007) (National Statement) states that research sites must be satisfied, before approving a clinical trial, that arrangements exist to ensure adequate compensation to participants for any injury suffered as a result of participation in the trial.

In the case of trials involving therapeutic goods that have not been approved by the Therapeutic Goods Administration, therapeutic goods legislation usually requires the approval by the Human Research Ethics Committees (HREC) in accordance with the National Statement. Accordingly, there is an ethical duty and, in most cases involving unapproved therapeutic goods, a legal requirement, to ensure adequate compensation. This would extend to having adequate insurance cover for human research.

For many research organisations, there are additional bases for the legal duty to ensure adequate insurance cover.

Roles and responsibilities in human research

The sponsor of a clinical trial determines what is to be trialled through drafting the trial protocol, and funds the conduct of the clinical trial. Pharmaceutical companies are common commercial sponsors of clinical trials.

The investigator of a clinical trial conducts the trial. The person with primary responsibility for the conduct of the trial is called the principal investigator who will often be a medical practitioner. Other investigators may include medical practitioners, nurses and allied health professionals.

Where the investigator is also the sponsor, the trial is an investigator-initiated clinical trial. Most trials of this kind are not conducted for profit.

The principal investigator is responsible for obtaining an approval for the proposed research from an appropriately constituted HREC.

Who needs to be covered by insurance?

Any person or organisation whose involvement in human research exposes them to significant potential liabilities should be covered. Each of the persons or organisations mentioned in the previous section needs to be covered by an adequate insurance policy.

Liabilities

Potential research liabilities come from either:

  • initiation or sponsorship of research including development of a research protocol; or
  • conduct of research.

Initiation of research

Sponsors or investigator-initiators may be liable to research participants due to:

  • professional negligence in the design of the research protocol, giving rise to professional liability;
  • the harmful effect of a product under investigation, giving rise to products liability; or
  • voluntarily agreeing to compensate injured participants on a no-fault basis, for example, in accordance with Medicines Australia’s guidelines for compensation.

Adequate clinical trial insurance should cover these risks.

The sponsor of a clinical trial will often have no direct relationship with research participants in the trial. Commercial sponsors of trials are required to give an indemnity to the research institution conducting the trial for any liabilities which are properly the responsibility of the sponsor. Commercial sponsors will often use the Medicines Australia standard form indemnity. Non-commercial sponsors or investigator-initiators also may be required to give an indemnity to research institutions in some circumstances.

Conduct of research

Conduct of research often includes the following activities:

  • selecting potential research participants and determining whether participation in the research is appropriate and will not expose potential participants to undue risks;
  • determining how the research protocol should be applied to the particular participant;
  • administering the product or procedure that is being investigated; and
  • monitoring the participant and ensuring that the participant’s involvement in the research is not causing the participant harm.

Liabilities may arise if any of the above activities are performed negligently and result in injury to a research participant.

Adequate clinical trial insurance should cover these risks for:

  • the research institution, its directors and officers;
  • the research institution’s HREC (if any);
  • the investigators except for medical practitioners;
  • medical practitioners, to the extent that their separate professional indemnity cover does not cover them.

Medical practitioners are required by law to be covered by approved professional indemnity insurance, generally through medical defence organisations or through an organisation’s self-insurance scheme. This insurance will generally cover potential human research liabilities for medical practitioners adequately, though some policies require the practitioner to notify their insurer of specific research involvement before the cover applies.

Treasury Managed Fund

Most research carried out by New South Wales public health system personnel, including medical practitioners, will be covered by the New South Wales Government’s self insurance scheme, the Treasury Managed Fund or TMF. The extent to which Staff Specialists Levels 2 5 and Visiting Medical Officers or VMOs will be covered by the TMF is currently under consideration by NSW Health. Any gaps in coverage must be covered by the practitioner’s professional indemnity cover.

Research in complex environments

Research often takes place in complex institutional environments involving multiple parties. This can complicate the issue of whether the proposed research is adequately insured. The following more complicated scenarios are common:

  • a commercially-sponsored clinical trial might be conducted in a medical research institute by a combination of institute personnel and university personnel;
  • an investigator initiator clinical academic may conduct research within a public hospital, to be carried out by a combination of university personnel and NSW Health personnel; or
  • a Visiting Medical Officer may be involved in the conduct of research which is otherwise entirely carried out by NSW Health personnel.

Getting insurance right

Insurance, and sometimes indemnity, is a necessary part of conducting human research. To ensure that approvals to conduct research are not delayed, and that research organisations are adequately insured in the event of a claim by a participant, it is necessary to get insurance and indemnity issues right.

 

Written by Geoff Bloom, Partner

Geoff Bloom has been commissioned by the NSW Office for Science and Medical Research (OSMR) to write a Guide to Insurance and Indemnity for Human Research in New South Wales and a series of brochures on Insurance and Indemnity for Human Research in New South Wales.

The Guide and the brochures will soon be available on OSMR’s website at www.osmr.nsw.gov.au.